To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces
the incidence of treatment-limiting adverse reactions compared to the routine initiation of
the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.

Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP
prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study
in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose
over 2 weeks, no significant adverse reactions have occurred.

Further study details as provided by
National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment:

370

Study Completion Date:

September 1996

Detailed Description:

Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP
prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study
in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose
over 2 weeks, no significant adverse reactions have occurred. Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or
routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients
will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000816